resorbable barrier for the prevention of abdominal and peri-hepatic adhesion formation

Conditions: Colorectal Cancer

Summary: the purpose of this study is to evaluate the efficiency of a resorbable barrier membrane for the prevention of abdominal and peri-hepatic adhesion in patients with colorectal cancer requiring two-stage surgery for the resection of hepatic metastases. eligible patients will be randomly assigned to one of 2 arms: * seprafilm group (receiving resorbable barrier membrane during the first surgery) * no-treatment control group (without seprafilm barrier during the first surgery) the primary objective is to establish, in patients with colorectal cancer requiring two-stage surgery for the resection of hepatic metastases, the efficiency of a resorbable barrier membrane (seprafilm) for limiting abdominal and peri-hepatic adhesion during the second operation. this study is a prospective multicentric phase ii, controlled, randomized and non comparative trial. a total of 60 patients will be enrolled: 45 will receive seprafilm whereas 15 will be assigned to the no-treatment control group. the inclusion period should be approximately 18 months. the follow up period after the second surgery will be 3 years.

the secondary objectives of the study are: during and after the 1st surgical procedure to evaluate immediate complications (during surgery), early complications (during post-surgery hospitalization) and late complications (between 1st and 2nd surgeries) in relation with operating procedure and use of resorbable membrane. during and after the 2nd surgical procedure * to evaluate abdominal and peri-hepatic adhesion (at the site of the 1st surgery), with qualitative and quantitative description. * to evaluate intestinal adhesion (in the small intestine), with quantitative description. * to evaluate immediate complications (during surgery), early complications (during post-surgery hospitalization) and late complications (in the month following the intervention) in relation with operating procedure. * to evaluate post-operative rehabilitation * to assess tumour evolution in patients over a period of 3 years after the 2nd surgery.

Eligibility criteria:
inclusion criteria: * women and men aged ≥ 18 years * colorectal cancer with synchronous or metachronous hepatic metastases * patients requiring two-stage surgery with laparotomy for the resection of hepatic metastases * the 2 operations should be scheduled in the same centre * the 2 operations should be scheduled at an interval of 1 to 6 months * patient affiliated with social security * patient able to read and write french * written, voluntary, informed consent exclusion criteria: * patient with previous hepatic or biliary surgery through supra-umbilical incision (except biliary surgery with laparotomy more than 6 months previously) * patient with previous major surgery except colorectal surgery for resection of primitive tumour * metastasis removable in one surgical procedure * non resectable metastasis * follow-up impossible for social, geographical, familial or psychological reasons * patient deprived of freedom * patient enrolled in another experimental surgery trial * pregnant or lactating woman

Keywords: colorectal cancer two stage surgery for the resection of hepatic metastases resorbable barrier membrane abdominal and peri-hepatic adhesion